NCT05050149

Study Evaluating the Safety and Efficacy of PTX-022 (QTORIN Sirolimus) in the Treatment of Microcystic Lymphatic Malformations

A Multicenter, Phase 2, Open-Label Study Evaluating The Safety And Efficacy of Sirolimus 3.9% Topical Gel (PTX-022) In The Treatment of Microcystic Lymphatic Malformations

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Palvella Therapeutics, Inc. · Industry
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the safety and efficacy of PTX-022 (sirolimus) Topical Gel 3.9% w/w in the treatment of Microcystic Lymphatic Malformations. The participant will receive 3 months of PTX-022 treatment by the end of the study.

Conditions

• Microcystic Lymphatic Malformation

Interventions

Type	Name	Description
DRUG	PTX-022	Safety and Efficacy of PTX-022 in the Treatment of Microcystic Lymphatic Malformations

Timeline

• Start date: 2022-01-13
• Primary completion: 2022-11-15
• Completion: 2022-12-15
• First posted: 2021-09-20
• Last updated: 2025-01-17
• Results posted: 2025-01-17

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study